MEDINAUT MAX

GUDID 08800038053007

MEDINAUT MAX Handpiece

IMEDICOM CO., LTD.

Multi-purpose surgical power tool system, rechargeable battery-powered

Primary Device ID	08800038053007
NIH Device Record Key	fe10247c-d322-4ef7-83a2-0a28e0d9fc19
Commercial Distribution Discontinuation	2021-10-22
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	MEDINAUT MAX
Version Model Number	BMH-100
Company DUNS	690340653
Company Name	IMEDICOM CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800038053007 [Primary]

FDA Product Code

KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment